BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Nano-Check Influenza+COVID-19 Dual Test

    K Number: K243561 · Decision Jun 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    10
    Applicant Total
    6
    Review Days
    211

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    Basic Information

    Device Name
    Nano-Check Influenza+COVID-19 Dual Test
    K Number
    K243561
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3987
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nano-Ditech Corporation
    Date Received
    November 18, 2024
    Decision Date
    June 17, 2025
    Product Code
    SCA
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SCA Multi-Analyte Respiratory Virus Antigen Detection Test

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    Other Clearances by Nano-Ditech Corporation

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